Genentech announced that the FDA has approved Erivedge (vismodegib capsules) for the treatment of adults with advanced basal cell carcinoma (BCC), that has spread to other parts of the body or that has come back after surgery or that their healthcare provider decides cannot be treated with surgery or radiation.
This approval was based on results from the ERIVANCE BCC (SHH4476g) study, an international, single-arm, multicenter, two-cohort, open-label, Phase 2 study that enrolled 104 patients with advanced BCC, including locally advanced BCC and metastatic BCC. Patients received Erivedge 150mg orally, once daily until disease progression or unacceptable toxicity. The study showed Erivedge shrank lesions (objective response rate, or ORR) in 43% of patients with locally advanced BCC and 30% of patients with metastatic BCC, as assessed by independent review, the primary endpoint of the study. The median duration of response was 7.6 months.

Erivedge is expected to be available in February 2012 and will be distributed through specialty pharmacies.

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